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Completed

NCT Number: NCT07697976

DRF Reposition Manual Reduction vs Finger-trap Traction

Participants with distal radius fractures treated conservatively with cast immobilization are assigned to one of two approaches: (1) closed reduction under local anesthesia (hematoma block) followed by traction and casting, or (2) traction and casting without formal reduction. While reduction aims to restore anatomical alignment, loss of reduction may occur during follow-up. The study evaluates whether reduction under local anesthesia provides any benefit over traction alone. The hypothesis is that both treatments result in comparable radiographic alignment and functional outcomes at the end of treatment.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Behavior Behavior, Animal Forearm Injuries Fractures, Bone Orientation, Spatial Radius Fractures Spatial Behavior Taxis Response Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ.-Klinik für Orthopädie und Traumatologie

Innsbruck, Tyrol, 6020, Austria

About this study

Participants have sustained a distal radius fracture treated with cast immobilization. Two common conservative management approaches are being compared: (1) closed reduction under a local anesthetic (hematoma block) followed by traction and casting, and (2) immobilization after traction alone without formal reduction under anesthesia.

While the first method aims to restore anatomical alignment initially, loss of reduction may occur over time. The second method improves alignment but does not attempt full anatomical reduction.

The study hypothesis is that both approaches result in similar wrist alignment and functional outcomes after completion of treatment. The objective of this study is to determine whether reduction under local anesthesia followed by traction provides any advantage over traction alone in patients with distal radius fractures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Dorsally tilted distal radius fracture (DRF) > 10° (intra-articular or extra-articular) Dorsal comminution of the distal radius fracture

Fracture classification (AO), dorsally displaced:

  • A2
  • A3
  • C1
  • C2
  • C3

Exclusion criteria

  • Age under 18 years
  • Non-displaced fractures of the radius
  • Previous palmar displaced fractures of the radius
  • Displacement greater than one shaft width
  • Open fractures of the radius
  • Bilateral radius fractures
  • History of a previous radius fracture
  • Inability to provide informed consent due to physical or mental disability
  • Unavailability for follow-up examinations (e.g., abroad, polytrauma)
  • Lack of full legal capacity
  • Alcohol or drug abuse
  • Allergy to local anesthetics
  • Median nerve irritation
  • Pregnancy

Treatment and study plan

Finger-trap traction

Procedure

15 minutes finger-trap traction only and then cast application

Manual reduction

Procedure

Hematoma block 5 mL 2% lidocaine, followed by 15 minutes finger-trap traction and then manual reduction + cast application

Primary outcomes

  1. Pain difference between the groups

    Time frame: From enrollment (Baseline) to the 12month Follow Up.

    Comparison of the pain score in the course of the follow ups between the groups. 0= no pain 10 = worst pain (maximal pain)

Secondary outcomes

  1. MHQ Hand Score (Patient reported outcome)

    Time frame: Enrollment until 12 month follow up

    Difference in functional outcome measured with MHQ (Michigan Hand Outcome Questionaire) between the two groups. 0 points= very poor hand function / maximum impairment; 100 points → optimal hand function, no impairment.

  2. PRWE - Patient reported outcome

    Time frame: Enrollment until 12month follow up

    Difference in functional outcome measured with PRWE (Patient-rated wrist evaluation) between the two groups. 0 points= optimal hand function, no impairment; 100 points → very poor hand function / maximum impairment.

  3. Grip strength

    Time frame: 12 weeks until 12mo Follow up

    Difference in grip strength measured with dynanometer between the two groups. Grip strength is compared to the contralateral non-injured wrist.

  4. Range of motion - functional outcome

    Time frame: 12 weeks until 12 mo follow-up

    Difference in functional outcome (range of motion) measured with goniometer after treatment between the two groups. Range of Motion is compared to the contraltaeral non-injured wrist.

  5. Radiological outcome

    Time frame: Enrollment until 12 month Follow up

    Difference in radiological outcome between the two groups; especially, dorsal tilt, radial inclination and ulnar variance.

  6. Complications

    Time frame: After treatment until 12 month Follow up

    Complications between the two groups.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Unterschied Der Reposition in Bruchspaltanästhesie Zur Reposition im Aushang Bei Einer Distalen Radiusfraktur - Eine Prospektiv Randomisierte Studie

Acronym: RepoDRF2

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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